PureWick Male PWM030Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741219153), received between Sep 7, 2022 and Sep 15, 2026 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient began using PureWick around (b)(6) while hospitalized at the (b)(6) Hospital. He was being treated for a pressure ulcer and a urinary tract infection. After being discharged, he continued to use PureWick at home, and a visiting nurse came almost every day to assist him. Today, the care manager in charge contacted us to say that, about three weeks after discharge, the patient was rushed to the hospital last night due to a suspected urinary tract infection.

  Patient problems: Urinary Tract Infection

  MAUDE report 50777736 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SINCE REIMPLEMENTATION OF EXTERNAL CATHETERS AS AN ALTERNATIVE TO INDWELLING CATHETER REPLACEMENT, (B)(6) HAS ALREADY EXPERIENCED AN INCREASE IN SYMPTOMATIC URINARY TRACT INFECTION RATES WITH MOST CASES INVOLVING AN EXTERNAL CATHETER. EXPLORING ROOT CAUSES ARE UNDERWAY. (B)(6) IMPLEMENTED PUREWICK FLEX (PWF030KX) AND PUREWICK MALE (PWM030) SEVERAL MONTHS AGO. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 24445550 ↗
• InjuryDec 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PUREWICK MALE EXTERNAL CATHETERS EDGE OF POUCH INSERTION HOLE CAUSED A PRESSURE INJURY TO THE SHAFT OF PATIENT'S PENIS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 23735147 ↗
• InjuryOct 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT NOTED TO HAVE INCREASED INCONTINENCE ASSOCIATED DERMATITIS. PATIENT CONTINUES TO HAVE INCONTINENCE OF STOOL AND URINE. A PUREWICK MALE EXTERNAL CATHETER WAS BEING USED TO CONTAIN/DIVERT URINE AWAY FROM SKIN. PER REPORT FROM AIDE, THE PUREWICK MALE EXTERNAL CATHETER HAD BEEN TAPED INTO PLACE YESTERDAY AND THE BEDSIDE NURSE USED BABY OIL TO REMOVE THE TAPE. CHARGE NURSE TODAY ALSO REPORTED THAT AREA WAS RED BUT NOT OPEN 2 DAYS AGO. PRIMARY TEAM AWARE; ALL ATTEMPTS MADE TO KEEP AREA CLEAN AND DRY WITH FREQUENT POSITION CHANGES AND PERI CARE. A CONDOM CATHETER WAS PLACED TO TRY TO KEEP ENTIRE GROIN AREA DRY. MICONAZOLE POWDER HAD BEEN ORDERED OVERNIGHT. ZINC OXIDE BARRIER CREAM ALSO APPLIED IN A THICK LAYER WITH EACH INCONTINENCE CARE/PRN. THIS IS THE 3RD - 4TH CASE OF HAVING A REACTION WITH THE PUREWICK MALE. I DO NOT THINK THESE CASES ARE EDUCATIONAL BASED BUT MORE SO THE BAG IS IRRITATING THE SKIN.

  Patient problems: Fecal Incontinence; Skin Discoloration; Urinary Incontinence

  MAUDE report 23370832 ↗
• InjurySep 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE REGISTERED NURSE STATED THAT THE SAFETY REPORT WAS INITIATED DURING NIGHT SHIFT FOR CIRCLE SKIN TEAR/EXCORIATION THAT WAS ASSESSED WHEN NIGHT SHIFT REGISTERED NURSE REMOVED PUREWICK MALE TO EXCHANGE FOR A NEW ONE. NIGHT SHIFT REGISTERED NURSE NOTICED THAT A CIRCULAR RED EXCORIATION/ SKIN TEARS THE SIZE OF A NICKEL THAT IS LOCATED ON THE POSTERIOR SHAFT OF THE MALE PENIS. PRIOR TO THAT, PATIENT WAS UTILIZING QUIVI FOR ABOUT 8-9 DAYS STRAIGHT BEFORE THE PUREWICK MALE WAS PLACED. PWM WAS ONLY ON PATIENT FOR 24 HOURS. THE NURSE PROVIDED FURTHER CLARIFICATION AND STATED, THAT THE SKIN AREA WHERE THE ADHESIVE OF THE PWM ADHERES TO REMAINED INTACT. CUSTOMER HAD A PHOTO OF THE SKIN TEAR; THEY MAY BE ABLE TO SHARE IF REQUESTED. NO MEDICAL INTERVENTION WAS REPORTED. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 04SEP2025, PCT WENT INTO ROOM TO REMOVE THE PUREWICK AND PLACE A NEW ONE. THE PUREWICK WAS PLACED ABOUT 5AM ON (B)(6) BY THE SAME PCT. WHEN THEY WENT TO REMOVE IT, THEY FOUND THE PATIENT WITHOUT HIS BRIEF AND THE PUREWICK WAS TWISTED. UPON REMOVING IT THEY SAW SKIN BREAK DOWN ON THE TOP OF THE PENILE SHAFT AND CALLED US. WE CAME AND ASSESSED THE INJU

  Patient problems: Pressure Sore/Ulcer; Tissue Breakdown

  MAUDE report 23037060 ↗
• InjuryAug 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT CUSTOMER REPORTED MULTIPLE PRESSURE ULCERS ON MALE GENITALIA RESULTING FROM USE OF PUREWICK MALE IN THE INTENSIVE CARE UNIT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pressure Sore/Ulcer

  MAUDE report 22895886 ↗
• InjuryJul 1, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENTS WERE EXPERIENCING REDNESS, BLISTERS AND INJURIES DUE TO SUCTION ISSUE OF PUREWICK MALE EXTERNAL CATHETER.

  Patient problems: Blister; Erythema; Skin Discoloration; Unspecified Tissue Injury

  MAUDE report 22374019 ↗
• MalfunctionMay 6, 2025Increase in Suction; Patient Device Interaction Problem; Increase in Suction; Patient Device Interaction Problem

  IT WAS REPORTED THAT AUTH ADVISED THE HOSPITAL USED SUCTION LEVEL 225 AND PATIENT GOT RAW. TROUBLESHOOTING WAS NOT PERFORMED. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. PATIENT USED PW IN THE HOSPITAL WITH MALE WICKS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21968092 ↗
• MalfunctionDec 29, 2022Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PLASTIC PIECE ON THE PUREWICK MALE CATHETER WAS STABBING AT THE BACK OF THE PATIENT THROUGH THE BED. IT WAS STATED THAT THE SHARP OBJECT WAS STRIPPING THE BED. IT WAS REPORTED THAT THE PATIENT WAS SUPPOSED TO BEGIN NEW PRODUCT IMPLEMENTATION ON THAT DAY BUT DECIDED TO POSTPONE AND STATED THAT THEY WOULD NEED TO VISIT THE PRODUCT WITH THEIR APPROPRIATE COMMITTEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16071013 ↗
• MalfunctionSep 7, 2022Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PUREWICK MALE EXTERNAL CATHETER WAS TRAILED THE PREVIOUS WEEK AND A RECAP CALL WAS HELD WITH THE KEY DECISION MAKERS. ONE OF THE DECISION MAKERS MADE A POINT TO CALL OUT THE SHARP EDGES IN THE BLUE PORT AND STATED THAT THIS WAS A PATIENT SAFETY CONCERN. IN ONE INSTANCE, THE BLUE PORT WAS BETWEEN A PATIENT'S LEGS AND INDENTIONS WERE LEFT. THEY FELT THAT IF IT HAD BEEN LEFT LONGER IT WOULD HAVE CAUSED A PRESSURE INJURY. TO EMPHASIZE THIS CONCERN, THEY MENTIONED ONE OF THEIR NURSES REPORTED FEELING LIKE THE BLUE PORT CUT THEM WHEN THEY WERE CONNECTING IT TO SUCTION. IN FACT, IT DID NOT CUT THEM BUT HIGHLIGHTED THE SHARPNESS OF THE PORT. THE AFFECTED LOTS WERE NGGTY113 AND UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15371529 ↗
• MalfunctionSep 7, 2022Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PUREWICK MALE EXTERNAL CATHETER WAS TRIALED THE PREVIOUS WEEK AND A RECAP CALL WAS HELD WITH THE KEY DECISION MAKERS. ONE OF THE DECISION MAKERS MADE A POINT TO CALL OUT THE SHARP EDGES IN THE BLUE PORT AND STATED THAT THIS WAS A PATIENT SAFETY CONCERN. IN ONE INSTANCE, THE BLUE PORT WAS BETWEEN A PATIENT'S LEGS AND INDENTIONS WERE LEFT. THEY FELT THAT IF IT HAD BEEN LEFT LONGER IT WOULD HAVE CAUSED A PRESSURE INJURY. TO EMPHASIZE THIS CONCERN, THEY MENTIONED ONE OF THEIR NURSES REPORTED FEELING LIKE THE BLUE PORT CUT THEM WHEN THEY WERE CONNECTING IT TO SUCTION. IN FACT, IT DID NOT CUT THEM BUT HIGHLIGHTED THE SHARPNESS OF THE PORT. THE AFFECTED LOTS WERE 5905406 AND UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15371514 ↗